According to Precedence Research, the global intravenous iron drugs market size was evaluated at US$ 3.24 billion in 2023 and is expected to attain around US$ 7.41 billion by 2033, growing at a CAGR of 8.62% from 2024 to 2033. North America intravenous iron drugs market share was 52% in 2023.
Iron is crucial for numerous vital biological processes, including the synthesis of heme, which forms hemoglobin (Hb) the protein responsible for oxygen transport in blood and myoglobin. It also contributes to energy metabolism, neurotransmitter production, collagen formation, and immune system function. Iron deficiency is a leading cause of anemia in the general population, highlighting its critical role in maintaining health. Iron deficiency anemia (IDA) is associated with increased morbidity and mortality rates. These factors underscore the importance of effective treatments like intravenous iron therapies, driving growth in the intravenous iron drugs market as they address critical health needs related to iron deficiency.
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Intravenous Iron Drugs Market Overview
The intravenous iron drugs market is experiencing rapid growth driven by its advantages over oral iron in treating iron deficiency anemia across various disease states, both with absolute and functional iron deficiency. Concerns over acute safety profiles and potential long-term toxicity with repeated use, seven different formulations are currently available, each with varying safety profiles. Confusion persists regarding their relative toxicities. Intravenous (IV) iron is preferred for iron replacement in conjunction with ESAs in chronic kidney disease (CKD), inflammatory bowel disease (IBD), and oncology patients undergoing chemotherapy-induced anemia. Multiple boluses of various formulations can be administered until the desired dose is achieved. Although safety has been demonstrated in numerous studies across diverse patient populations, concerns remain about hypersensitivity reactions. Newer intravenous iron formulations, dextran-free and without the need for test doses, show promise for quicker iron repletion and improved safety profiles, contributing to the market’s expansion.
What are the intravenous (IV) iron drugs market trends?
· Rising Prevalence of Chronic Diseases: Chronic kidney disease (CKD), cancer, and inflammatory bowel disease (IBD) are major drivers for the demand for IV iron drugs. CKD, in particular, is a significant segment due to the high prevalence of iron deficiency anemia (IDA) among CKD patients.
· Advancements in IV Iron Formulations: Ferric carboxymaltose (FCM) has emerged as a leading IV iron drug due to its effectiveness, safety, and cost-efficiency. It is preferred for its high-dose iron replenishment capabilities and is used for treating various forms of anemia, including those related to cancer and CKD.
· Impact of COVID-19: The pandemic has influenced the market by increasing the incidence of CKD and acute kidney injury (AKI) among hospitalized COVID-19 patients, thereby boosting the demand for IV iron drugs.
· Regulatory Approvals and Product Launches: New product launches and approvals are critical for market expansion. For example, the FDA’s approval of drugs like INJECTAFER for specific conditions has been pivotal in driving market growth.
Key Insights
· Asia Pacific is expected to expand at the fastest CAGR during the forecast period.
· By product, the ferric carboxymaltose segment has accounted market share of 48% in 2023.
· By application, the chronic kidney disease segment has accounted revenue share of 35% in 2023.
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Regional Stance
North America currently dominates the intravenous iron drugs market, holding the largest share. In the United States, up to 40% of females aged 12 to 21 may experience iron deficiency, underscoring the significant demand for effective treatments. Ferinject (ferric carboxymaltose) stands out as a prominent IV iron therapy with marketing authorization in 87 countries as of March 2024. In Canada, Ferinject is approved for treating iron deficiency anemia in both pediatric patients from age one and older, and adults, particularly when oral iron preparations are inadequate or not tolerated. It is also indicated for improving exercise capacity in adult heart failure patients with NYHA class II/III. Diagnosis of iron deficiency relies on laboratory tests, a standard practice supported by multiple global health organizations like the World Health Organization (WHO), UNICEF, and the U.S. Agency for International Development (USAID), which advocate for comprehensive anemia monitoring frameworks. This regional landscape underscores North America’s pivotal role in driving advancements and adoption of intravenous iron therapies to address diverse clinical needs effectively.
· In June 2023, Injectafer was approved in the U.S. for the treatment of iron deficiency in patients with heart failure.
Asia Pacific is poised to experience rapid growth in the intravenous iron drugs market over the forecast period. Anemia remains a significant health challenge in many developing countries across Asia. Studies investigating the relationship between the Human Development Index (HDI) and anemia prevalence among Asian women highlight the urgent need for interventions to address contributing factors. Raising awareness and comparing data with other countries can aid in planning and allocating resources effectively to combat anemia. It is crucial for countries in the region to implement targeted interventions, considering socioeconomic influences on the root causes of anemia, to reduce its incidence and improve public health outcomes. This dynamic environment presents substantial growth opportunities for intravenous iron therapies to meet the healthcare needs of diverse populations in Asia Pacific.
· In November 2023, Shionogi obtained manufacturing and marketing approval in Japan for the new siderophore cephalosporin antibiotic Fetroja (cefiderocol) intravenous infusion 1g vial.
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Report Highlights
By Product
Ferric carboxymaltose (FCM) commands the largest share of the intravenous iron drugs market and is anticipated to maintain its dominance in the forecast period. FCM is highly effective for treating iron-deficiency anemia (IDA) by delivering a substantial iron dose efficiently. It can provide up to 1500 mg of iron through two administrations of 750 mg each, spaced at least a week apart. FCM offers flexibility in administration, either as a 15-minute intravenous infusion or as a slow push over at least 7.5 minutes. This versatility makes it suitable for patients, including adults and children aged one year and older, who are unable to tolerate or benefit from oral iron supplements. FCM’s ability to swiftly and effectively replenish iron stores positions it as a cornerstone therapy in managing IDA, contributing significantly to its market leadership and continued growth outlook.
By Application
The chronic kidney disease (CKD) segment plays a pivotal role in driving the intravenous iron drugs market. Iron supplementation, particularly through intravenous administration, significantly enhances erythropoiesis and increases hemoglobin (Hb) levels in CKD patients with anemia, even in cases where traditional iron markers like transferrin saturation (TSAT) and ferritin levels do not indicate absolute iron deficiency. Intravenous iron treatments have consistently shown to improve the erythropoietic response to erythropoiesis-stimulating agent (ESA) therapy. Various intravenous iron agents are available to replenish iron stores in CKD patients diagnosed with iron deficiency. The choice of agent often hinges on therapeutic goals, patient tolerability, convenience of administration, and response to previous therapies. This targeted approach underscores the critical role of intravenous iron drugs in optimizing outcomes for CKD patients by effectively managing anemia and supporting erythropoietic function in clinical practice.
Market Dynamics
Driver
Advantages and Safety of Modern Formulations
Modern formulations of intravenous (IV) iron have emerged as superior and safe alternatives for managing iron deficiency anemia (IDA), offering faster and higher increases in hemoglobin levels and replenishing body iron stores effectively. The effectiveness and safety profiles of IV iron, particularly iron sucrose (IS) and ferric carboxymaltose, have been demonstrated across a wide range of diseases associated with IDA. This challenges the current paradigm where oral iron is considered first-line therapy, suggesting a need for clinical trials in nephrology, gynecology, gastroenterology, oncology, and hematology to evaluate more rapid administration of larger iron doses. IV iron is generally safer than commonly perceived by physicians. Proper utilization of this therapeutic modality promises significant clinical benefits by reducing morbidity and mortality associated with various conditions linked to iron deficiency, thereby driving growth in the intravenous iron drugs market.
Restraint
Side Effects and Safety Concerns
The growth of the intravenous iron drugs market faces significant limitations due to potential side effects and safety concerns associated with iron infusions. These include bloating or swelling of the face, arms, hands, lower legs, or feet, dizziness upon sudden changes in posture, gastrointestinal discomfort such as nausea or diarrhea, breathing difficulties, constipation, headaches, joint or muscle pain, skin reactions like rashes, chest pain, low blood pressure, and in severe cases, anaphylaxis. These adverse effects pose challenges to widespread adoption and utilization of intravenous iron therapies, necessitating careful consideration of patient safety and management strategies within the healthcare sector.
Opportunity
Advances in Pharmaceutical Technologies
Recent advancements in pharmaceutical technologies are driving the development of newer iron formulations aimed at mitigating challenges associated with traditional approaches. The distinct pharmacokinetics of oral versus parenteral iron have become increasingly apparent, particularly in light of hepcidin’s pivotal role in regulating systemic iron homeostasis. Enhanced understanding of iron metabolism’s pathophysiology and innovative pharmaceutical technologies have underscored the necessity for intravenous (IV) formulations for iron replacement. These advancements address situations where oral iron preparations are ineffective or unsuitable, thereby presenting significant growth opportunities in the intravenous iron drugs market.
Recent Developments
· In April 2024, the Commission sought feedback on commitments offered by Vifor regarding possible anticompetitive disparagement of iron medicine.
· In November 2022, Ferinject was approved in China for the treatment of iron deficiency in adult patients.
Who are the key players operating in the Intravenous Iron Drugs Market?
· Allergan Plc.
· AMAG Pharmaceuticals, Inc.
· Daiichi Sankyo, Inc.
· Luitpold Pharmaceuticals, Inc.
· American Regent, Inc.
· Pharmacosmos A/S
· Sanofi US
· Vifor Pharma Ltd.
Market Segmentation
By Product
· Iron Sucrose
· Iron Dextran
· Ferric Carboxymaltose
By Application
· Chronic Kidney Disease
· Inflammatory Bowel Disease
· Cancer
· Other Disease
By Geography
· North America
· Europe
· Asia Pacific
· Latin America
· Middle East & Africa (MEA)
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